Clinical Investigation on Medical Device: A data model based on HL7 reference information model.

Information on Clinical investigations (CIV) of new drugs and/or medical devices (MDs) is generally managed by registries. Although the majority of them concern pharmaceutical products, the European Community is developing a databank (EUDAMED) that manages this information. In Italy the National Research Council is carrying out a project supported by the Ministry of Health to develop an information system (MEDIS) that manages CIVs on MDs. In order to facilitate the interoperability with EUDAMED MEDIS design and development has been based on the application of HL7 (Health Level 7) v.3 standards. Moreover the Domain Analysis Model (DAM) has been adopted to design and develop a logical data model. This paper presents the results of the design of MEDIS database providing motivations of the approach used depending on system requirements as well as on the domain characteristics. © 2010 IADIS.